FDA Globalization
In today's world, other countries produce significant portions of the food and medical products that U.S. consumers and patients use in their daily lives. There are nearly 300,000 FDA-registered facilities manufacturing or handling FDA-regulated products, of these, more than half are located outside of the United States. FDA-regulated products account for 19% of U.S. imports. About 78% of active pharmaceutical ingredient manufacturers are located outside of the U.S. and imports account for about 49% of medical devices used in the U.S. and 96% of biologics sales. Imports also account for about 59% of fresh fruit, 35% of vegetables, and 91% of seafood consumed by volume.
FDA faces ever-greater challenges in determining whether a product has been properly manufactured, distributed, and stored and even in determining who has handled the product. The manufacture of a single product can now involve multiple parties from different countries that are engaged at various steps throughout the process. Along the way, there are opportunities for the product to be improperly formulated or packaged, contaminated, diverted, counterfeited, or adulterated. FDA has mobilized diverse approaches as part of its strategy to address the complex issues posed by globalization, including efforts to:
- Develop new enforcement and regulatory tools.
- Conduct more foreign inspections.
- Increase collaboration with foreign regulators and other stakeholders.
- Develop internationally-harmonized standards and standards convergence.
- Educate foreign industry about FDA requirements.
- Increase transparency and accountability in the supply chain.
Responsibility for addressing these global issues is distributed across the agency. The Office of Inspections and Investigations conducts inspections and reviews imported products offered for entry into the United States. FDA’s product centers focus on international policy and outreach that touches on their portfolio of regulated products and the Office of Global Policy and Strategy serves as a focal point for FDA-wide coordination and information sharing and a point of access to multilateral organizations; addresses issues related to international trade of regulated products and mutual recognition agreements; enters into arrangements that facilitate the sharing of information with global regulatory counterparts; and manages FDA’s foreign offices around the world.
For more information:
- Office of Global Policy and Strategy
- Office of Inspections and Investigations
- Center for Biologics Evaluation and Research International Activities
- Center for Drug Evaluation and Research International Program
- Center for Devices and Radiological Health International Affairs
- Cosmetics International Activities
- Human Foods Program International Activities
- Center for Tobacco Imports and Exports
- Center for Veterinary Medicine International Affairs
Beginning in 2008, FDA established foreign offices, posting staff in strategic locations around the world, including China, Europe, India, Latin America, and Rwanda. FDA offices overseas work closely with foreign governments, industry, and other stakeholders to enable FDA to more effectively protect U.S. consumers.
Globalization Contacts
Office of Global Policy and Strategy
10903 New Hampshire Avenue
Building 1
Silver Spring, MD 20993
Resources For You
- U.S. Department of Health and Human Services
- Centers for Disease Control and Prevention
- National Institutes of Health (NIH)
- U.S. Trade Representative
- U.S. Department of Agriculture
- Department of Commerce's Foreign Commercial Service
- U.S. Department of State